JAA · System, X-Ray, Fluoroscopic, Image-Intensified
Radiology · 21 CFR 892.1650 · Class 2
Overview
| Product Code | JAA |
|---|---|
| Device Name | System, X-Ray, Fluoroscopic, Image-Intensified |
| Regulation | 21 CFR 892.1650 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Special Controls
*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Recent Cleared Devices (20 of 299)
Showing 20 most recent of 299 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251650 | Insight Enhanced DRF (EN-1002-01) | Imaging Engineering, LLC | Sep 16, 2025 | SESE |
| K242488 | Soteria E-View | Omega Medical Imaging, LLC | Jan 6, 2025 | SESE |
| K242948 | Adora DRFi (04550010) | Nrt X-Ray A/S | Dec 23, 2024 | SESE |
| K233380 | TRIDENT Mobile Fluoroscopy System | Dornier Medtech America | Jun 26, 2024 | SESE |
| K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400) | Philips Medical Systems Dmc GmbH | Jan 11, 2024 | SESE |
| K232910 | CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | Oct 19, 2023 | SESE |
| K232526 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 | Canon Medical Systems Corporation | Sep 12, 2023 | SESE |
| K220871 | Nautilus | Dornier Medtech America, Inc. | Apr 18, 2022 | SESE |
| K212890 | Nyquist.IQ | Omega Medical Imaging, LLC | Dec 13, 2021 | SESE |
| K212837 | ProxiDiagnost N90 | Philips Medical Systems Dmc GmbH | Sep 21, 2021 | SESE |
| K212145 | DR 800 with DSA, DR 800 | Agfa N.V. | Aug 31, 2021 | SESE |
| K210469 | Insight Agile DRF | Imaging Engineering, LLC | Jul 27, 2021 | SESE |
| K203428 | Ziehm Vision RFD | Ziehm Imaging GmbH | Mar 17, 2021 | SESE |
| K203010 | Platinum dRF Imaging System | Apelem-Dms Group | Jan 22, 2021 | SESE |
| K200965 | XR-MX/1000 | Karl Storz Endoscopy America, Inc. | Dec 29, 2020 | SESE |
| K203087 | CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | Dec 3, 2020 | SESE |
| K202235 | ArtPIX DRF | Cmt Medical Technologies, Ltd. | Sep 3, 2020 | SESE |
| K200396 | Insight Enhanced DRF Digital Imaging System | Imaging Engineering, LLC | Mar 6, 2020 | SESE |
| K191713 | CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly) | Omega Medical Imaging, LLC | Oct 4, 2019 | SESE |
| K191504 | PowerDR | Radiology Information Systems, Inc. | Aug 16, 2019 | SESE |
Top Applicants
- Toshiba America Medical Systems, In.C — 13 clearances
- Siemens Medical Solutions USA, Inc. — 10 clearances
- Shimadzu Medical Systems — 10 clearances
- General Electric Co. — 10 clearances
- Fischer Imaging Corp. — 10 clearances
